510(k) Report

Devices descending from K023231

63 later devices reach Elfcare Device, Models 314A Through 314G through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K072152Juniper CLN1 Dermal Cooling DeviceJuniper Medical, Inc.200734—
+1K070299Ezfit Digital Heating Tens (Model NO.: HR-661/UC-101)Ezfit Technology, Inc.200726—
+1K063715Juniper Cooling Device XtraJuniper Medical, Inc.200735—
+2K162517Electronic Pulse Stimulator Model: PL-029K12 and PL-029K13Jkh Health Co., Ltd.201725—
+2K080118Zeltiq Aesthetics CLN1 Dermal Cooling DeviceZeltiq Aesthetics200833—
+3K211403HIVOX OTC Electrical Stimulator, FT610-BHivox Biotek, Inc.20213—
+3K203574HIVOX OTC Electrical Stimulator, EM59-l, HIVOX OTC Electrical Stimulator, EM59-2Hivox Biotek, Inc.20214—
+3K200561StimPlus Patch, StimPlus Patch, StimPlus PatchJkh Health Co., Ltd.20202—
+3K193275Nerve and Muscle StimulatorShenzhen Xft Medical Limited20202—
+3K192733RelieforMe TENS/EMS Device Model UPK-GE01Umeheal, Ltd.20191—
+3K182671Medi-Direct TENS PenJkh USA, LLC20190—
+3K182203JKH Stimulator PlusJkh USA, LLC20197—
+3K090094Zeltiq SystemZeltiq Aesthetics200932—
+4K252767actiTENS miniSublimed20260—
+4K223027NeuroTrigger Basic (NTB)Neurotrigger20230—
+4K232675Heating Tens, FT-615Hivox Biotek, Inc.20230—
+4K223151Nu-beca Transcutaneous Electrical Nerve StimulationNu-Beca & Maxcellent Co.20230—
+4K223308Heating Tens/Ems, FT-810RHivox Biotek, Inc.20230—
+4K221251Ems Foot Stimulator (model: HK701, HK701A, HK701B, HK701C)Guangzhou Huakai Electronic Technology Co., Ltd.20220—
+4K220738Motive Knee WrapCymedica Orthopedics, Inc.20220—
+4K213091Well-Life TENS/EMS/Heating StimulatorWell-Life Healthcare Limited20220—
+4K211942Heating Lumbar Therapy Cushion (Model: AST-622, AST-622B, AST-623, AST-623B)Shenzhen Osto Technology Company Limited20211—
+4K212918Heat StimPlusFamidoc Technology Co., Ltd.20210—
+4K202159actiTENSSublimed20201—
+4K201431OGYILI TENS/NMES StimulatorGongguan Tutamen Metalwork Co., Ltd.20200—
+4K191151JKH Stimulator PlusJkh USA, LLC20194—
+4K120023Zeltiq CoolsculptingZeltiq Aesthetics, Inc.201231—
+5K241119Transcutaneous Electrical Nerve Stimulator (K6106)Shenzhen Yicai Health Technology Co., Ltd.20240—
+5K231569ManaFlexx 2 (model: MF002-RX, MF002-OTC)Manamed, Inc.20231—
+5K223428Electronic Stimulator (Models: uLumb-9530A, uLumb-9531A, uLumb-9532A, uLumb-9533A…Shenzhen Leqing Medical Instrument Co., Ltd.20230—
+5K212989Low-frequency Stimulator (Model: AST-645, AST-646)Shenzhen Osto Technology Co., Ltd.20210—
+5K151179ZELTIQ CoolSculpting SystemZeltiq Aesthetics, Inc.201526—
+5K142491ZEL TIQ CoolSculpting SystemZeltiq Aesthetics, Inc.201527—
+5K133212Zeltiq Coolsculpting SystemZeltiq Aesthetics, Inc.201430—
+6K243613Patch-TEA (Model TRI-21)Transtimulation Research, Inc.20250—
+6K160470SculpSureCynosure, Inc.201620—
+6K160259ZELTIQ CoolSculpting SystemZeltiq Aesthetics, Inc.201615—
+6K150724SculpSureCynosure, Inc.201521—
+6K150230SculpSureCynosure, Inc.201521—
+7K211681EONDominion Aesthetic Technologies, Inc.20221—
+7K191068Powersculp laser lipolysis systemWuhan Lotuxs Technology Co., Ltd.20196—
+7K190743Venus BlissVenus Concept USA, Inc.20194—
+7K171111SculpsureCynosure, Inc.201710—
+7K162050ZELTIQ CoolSculpting SystemZeltiq Aesthetics, Inc.201614—
+8K233962ReBorn (1050nm)Lightfective, Ltd.20240—
+8K222226EONDominion Aesthetic Technologies, Inc.20230—
+8K222265DiosculptShanghai Wonderful Opto-Electrics Tech.Co.,Ltd20220—
+8K213308Venus BlissMAXVenus Concept USA, Inc.20222—
+8K212331BodySculpRohrer Aesthetics, LLC20211—
+8K211402Powersculp laser lipolysis systemLotuxs Medtech (Suzhou) Co., Ltd.20210—
+8K192970SlimusHironic Co., Ltd.20200—
+8K201731Diode Laser Body Sculpture SystemShanghai Apolo Medical Technology Co., Ltd.20201—
+8K171992SculpSureCynosure, Inc.20178—
+8K171069ZELTIQ CoolSculpting SystemZeltiq Aesthetics, Inc.20178—
+9K233099GladiatorRohrer Aesthetics, LLC20240—
+9K2406581060nm laser body slimming machineHebei JT Medical Co., Ltd.20240—
+9K231971Deka Physiq 360El.En S.P.A.20230—
+9K220592Venus BlissMAXVenus Concept USA, Inc.20221—
+9K182741SculpSureCynosure20195—
+9K172144CoolSculpting SystemZeltiq Aesthetics20177—
+10K252845Venus Nova (FP-2001)Venus Concept, Inc.20250—
+10K231131Diode Laser Body Sculpture SystemsShanghai Bele Medical Technology Co.,Ltd20230—
+10K181740ZELTIQ CoolSculpting SystemZeltiq Aesthetics, Inc.201805